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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Does Your Spouse Affect How you Perceive Drug Safety? An FDA Study Aims to Find out

Posted 13 November 2014 | By Alexander GaffneyRAC

The US Food and Drug Administration (FDA) has announced another proposed study of consumers who watch drug advertising on TV—the second this week—this time trying to assess how spouses influence how consumers understand a drug's benefits and risks.

Background

FDA frequently studies consumer behavior as it related to drug advertising. An overview of recent studies is as follows:

Study to assess how repeated exposure to a single drug ad changes consumer behavior over time.

FDA's various studies have focused in large part on the ways in which consumers view DTC advertising, and how a wide range of factors can impact their assessment of a drug's benefits and risks.

New Study Proposed

Unlike most of the studies FDA has proposed since 2012, FDA's latest proposal focuses on the "social contexts" in which a direct-to-consumer advertisement is seen. Specifically, FDA notes that a "potential consumer and his or her spouse (e.g. marital or domestic partner) may view an ad together and discuss drug benefits, side effects and risks."

"These social interactions may result in unique reactions relative to consumers who view DTC prescription drug ads alone," FDA continues in its 13 November 2014 Federal Register notice. A person's spouse, for example, may express their concern about a particular risk posed by a drug, leading the person to take a more negative view of the drug.

To study whether spouses have an effect on how a drug's benefits and risks are perceived, FDA's Office of Prescription Drug Promotion (OPDP) plans to study participants under a variety of conditions.

Participants will be shown one of two advertisements: one which depicts a low-benefit and low-risk drug, and another depicting a high-benefit and high-risk drug. Patients will be randomly assigned to either view the ad alone or with their spouse, FDA said. Participants viewing the ad with their spouse will be given time to discuss the ad together before answering a survey.

The study will focus on patients with asthma. Spousal participants in the study should not have the condition, FDA said.